ahn international inc – FDA Warning Letter, May 30, 2012

On May 23-30, 2012, an FDA inspection of Amazing Herbs, a dietary supplement firm, revealed serious violations of CGMP regulations (21 CFR Part 111), rendering products adulterated. Many violations were repeat observations from a February-March 2011 inspection. Additionally, "Bitter Melon" and "Black Seed" products were deemed unapproved new drugs and misbranded due to therapeutic claims on their website (www.amazingherbs.com) and in associated books, promoting them for conditions like diabetes, HIV/AIDS, cancer, and hypertension.

Specific CGMP violations included: 1. Failure to verify identity of dietary ingredients (e.g., black seed oil, flax seed oil) prior to use (21 CFR 111.75(a)(1)(i)). 2. Failure to prepare and follow written master manufacturing records for each unique formulation and batch size (21 CFR 111.205(a)). 3. Failure to prepare batch production records for manufactured dietary supplements (21 CFR 111.255(a)). 4. Quality control personnel failed to approve or reject processes, specifications, procedures, and tests (21 CFR 111.105(a)). 5. Quality control failed to approve and release, or reject, each finished batch for distribution (21 CFR 111.1